DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 14 and 18 are objected to because of the following informalities:
in claim 14, line 16: “anesthesia drug and dose of the anesthesia drug” should be “the general anesthesia drug and the dose of the general anesthesia drug”; and
in claim 18, line 10: “at or near at or near” should be “at or near”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 5-7, 9, 11, 13-15, and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recite “wherein the reference signals are representative of local or network neural activity signal associated with a state of arousal at or near the anatomical locations” in lines 8-10, but it is not clear if “local or network neural activity signal” is supposed to be singular or plural. The Applicant’s deletion of “a” before “local or network neural activity signal” in the amendment suggests that it is not intended to be singular while the lack of an “s” after “signal” suggest that it is intended to be singular. Clarification is required.
Claim 1 recites “compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion” in lines 15-16, but it is not clear if the selection of the reference signal is a result or consequence of the comparison. The recitation itself does not make a causal link between the two actions; however the placement of the two actions in the same indentation suggests that their might be a causal link. Clarification is required.
Claim 1 recites “the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal” in lines 17-18, but it is not clear if this recitation is the same as, related to, or different from the action of “compare the one or more sensed evoked resonant neural activity signals to the reference signals” of claim 1, lines 15-16. The recitation of claim 1, lines 15-16 says there is a comparison between the one or more sensed evoked resonant neural activity signals and the reference signals while the recitation of claim 1, lines 17-19 says there is a comparison between the one or more sensed evoked resonant neural activity signals and the selected reference signal. This variation in phraseology connotes that they are different. If they are the same, consistent terminology should be used. If they are different, the relationship between the two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for “the comparison” of lines 17-19 in this claim.
Claim 1 recites “when…the one or more sensed evoked resonant neural activity signals match the selected reference signal” in lines 21-23, which seems to connote a possible condition of the one or more sensed evoked resonant neural activity signals matching the selected reference signal. However, claim 1 also provides “compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion” in lines 15-16, which seems to connote that, according to one interpretation, the reference signal by definition is selected because it matches the one or more sensed evoked resonant neural activity signals. It is unclear how to reconcile how the one or more sensed evoked resonant neural activity signals can conditionally match a selected reference signal when the selected reference signal is defined by matching the one or more sensed evoked resonant neural activity signals. This ambiguity renders claim 1 indefinite.
Claims 2, 5-7, 9, and 11 are rejected by virtue of their dependence from claim 1.
Claim 6 recites “select a reference signal that is a baseline spontaneous neural activity signal associated with the state of arousal” in lines 3-4, but it is not clear if this recitation is the same as, related to, or different from “select a reference signal using a matching criterion” of claim 1, line 16. Both recitations refer to a selection of a reference signal which suggests that they are the same. However, the use of the indefinite article before “reference signal” in claim 6 and the lack of a connection between the two recitations suggests that they are different. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 7 recites “a general anesthesia drug” in line 2, but it is not clear if this recitation is the same as, related to, or different from “general anesthetic drug” of claim 1, lines 7-8. If they are the same, “a general anesthesia drug” in claim 7 should be “the general anesthesia drug”. If they are different, their relationship should be made clear; they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements); and any subsequent recitation (such as in claim 7, lines 4-5) should make it clear which recitation is being referred to.
Claim 9 recites “the reference signal” in lines 4-5, but it is not clear if this recitation is referring to one, each, or all of the reference signals of claim 1, lines 6-7 and/or the selected reference signal of claim 1, line 16. Clarification is required.
Claim 11 recites “the reference signal” in line 3, but it is not clear if this recitation is referring to one, each, or all of the reference signals of claim 1, lines 6-7 and/or the selected reference signal of claim 1, line 16. Clarification is required.
Claim 13 recites “general anesthesia” in line 9, but it is not clear if this recitation is the same as, related to, or different from the “general anesthetic drug” of claim 13, line 7. If they are the same, “general anesthesia” in line 9 should be “the general anesthesia drug”. If they are different, their relationship should be made clear.
Claim 13 recites “the one or more sensed evoked resonant neural activity signals” in lines 17-18 and “the one or more sensed evoked resonant neural activity signals” in line 22, but it is not clear if these recitation are the same as, related to, or different from “one or more neural activity signals” that are sensed in claim 13, line 3. If they are the same, “the one or more sensed evoked resonant neural activity signals” in lines 17-18 and “the one or more sensed evoked resonant neural activity signals” in line 22 should both be “the one or more sensed neural activity signals”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 13 recites “when…the one or more sensed evoked resonant neural activity signals match the selected reference signal” in lines 21-23. Assuming “the one or more sensed evoked resonant neural activity signals” is the same as “one or more neural activity signals” that are sensed in claim 13, line 3, this recitation seems to connote a possible condition of the one or more sensed neural activity signals matching the selected reference signal. However, claim 13 also provides “matching the one or more sensed neural activity signals to select a reference signal of the multiple stored reference signals” in lines 13-14, which seems to connote that, according to one interpretation, the reference signal by definition is selected because it matches the one or more sensed neural activity signals. It is unclear how to reconcile how the one or more sensed neural activity signals can conditionally match a selected reference signal when the selected reference signal is defined by matching the one or more sensed neural activity signals. This ambiguity renders claim 13 indefinite.
Claims 14-15 and 17 are rejected by virtue of their dependence from claim 13.
Claim 14 recites “generating an indication via the user interface that the implantable electrode is positioned at the target anatomical location corresponding to the selected reference signal when the one or more sensed neural activity signals match the selected reference signal” in lines 3-5, but it is not clear if this recitation is the same as, related to, or different from “generating an indication that the implantable electrode is positioned at a target anatomical location corresponding to the selected reference signal when the determined depth of anesthesia corresponds to the received anesthesia state information and the one or more sensed evoked resonant neural activity signals match the selected reference signal” of claim 13, lines 19-23. Both recitations seem to allude to the same indication being generated, but the use of the indefinite article before “indication” and the lack of the condition “when the determined depth of anesthesia corresponds to the received anesthesia state information” in claim 14 seems to connote that they are different. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). If they are the same, it is not clear how the recitation of claim 14 further defines the invention.
Also, the recitation “when the one or more sensed neural activity signals match the selected reference signal” in claim 14, lines 3-5 suffers from the same indefiniteness issue as “when…the one or more sensed evoked resonant neural activity signals match the selected reference signal” in claim 13, lines 21-23. Assuming “the one or more sensed evoked resonant neural activity signals” is the same as “one or more neural activity signals” that are sensed in claim 13, line 3, this recitation seems to connote a possible condition of the one or more sensed neural activity signals matching the selected reference signal. However, claim 13 also provides “matching the one or more sensed neural activity signals to select a reference signal of the multiple stored reference signals” in lines 13-14, which seems to connote that, according to one interpretation, the reference signal by definition is selected because it matches the one or more sensed neural activity signals. It is unclear how to reconcile how the one or more sensed neural activity signals can conditionally match a selected reference signal when the selected reference signal is defined by matching the one or more sensed neural activity signals. This ambiguity renders claim 14 indefinite.
Claim 15 recites “determining the anatomical location of the implantable electrode by matching the one or more sensed neural activity signals to the selected reference signal” in lines 3-4, but it is not clear if this recitation is the same as, related to, or different from the determination implied by the recitation “generating an indication that the implantable electrode is positioned at a target anatomical location corresponding to the selected reference signal when the determined depth of anesthesia corresponds to the received anesthesia state information and the one or more sensed evoked resonant neural activity signals match the selected reference signal” of claim 13, lines 19-23. Both recitations seem to allude to the same determination of the anatomical location of the implantable electrode by matching the one or more sensed neural activity signals to the selected reference signal. However, the claim structure appears to treat them as being different. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements). If they are the same, it is not clear how the recitation of claim 15 further defines the invention.
Claim 17 recites “the electrical neurostimulation stimulus” in lines 2-3 in which there is insufficient antecedent basis for this limitation in the claim. Relatedly, it is not clear if this recitation is the same as, related to, or different from “electrical neurostimulation” of claim 13, line 2. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 17 recites “wherein the one or more sensed neural activity signals includes a local evoked resonant neural activity signal sensed near a location of the electrical neurostimulation stimulus and the method includes initiating the local evoked resonant neural activity signal using the medical system” in lines 1-4, but it is not clear if this recitation is the same as, related to, or different from “delivering electrical neurostimulation to evoke neural activity of a subject” of claim 13, line 2. They seem to be alluding to the same stimulation to the subject, but the phraseology between the two recitations is different. Clarification between these two recitations are required.
Claim 18 recites “a general anesthesia drug” in lines 9-10, “anesthesia drug” in line 20, and “the selected anesthesia drug” in line 20, but it is not clear if these recitations are the same as each other or the “general anesthetic drug” of claim 18, line 7. If they are the same,” a general anesthesia drug” in lines 9-10, “anesthesia drug” in line 20, and “the selected anesthesia drug” in line 20 should be “the general anesthetic drug”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 18 recites “one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug” in lines 13-14, but it is not clear if this recitation is the same as, related to, or different from “one or more of a type of general anesthetic drug and a dose of the general anesthetic drug” in claim 18, lines 7-8. If they are the same, “the” should be inserted before the recitation of lines 12-14. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 18 recites “the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal” in lines 23-24, but it is not clear if this recitation is the same as, related to, or different from the action of “compare the one or more sensed evoked resonant neural activity signals to those reference signals of the multiple reference signals corresponding to the indication of the one or both of the type of anesthesia drug and the dose of the selected anesthesia drug” of claim 18, lines 18-20. The recitation of claim 18, lines 18-20 says there is a comparison between the one or more sensed evoked resonant neural activity signals and those reference signals while the recitation of claim 18, lines 23-24 says there is a comparison between the one or more sensed evoked resonant neural activity signals and the selected reference signal. This variation in phraseology connotes that they are different. If they are the same, consistent terminology should be used. If they are different, the relationship between the two recitations should be made clear. Also, if they are different, there is insufficient antecedent basis for “the comparison” of lines 23-24 in this claim.
Claim 18 recites “when … the one or more sensed evoked resonant neural activity signals match the selected reference signal” in lines 28-30, which seems to connote a possible condition of the one or more sensed evoked resonant neural activity signals matching the selected reference signal. However, claim 18 also provides “match the one or more sensed evoked resonant neural activity signals to a selected reference signal of the multiple reference signals” in lines 21-22, which seems to connote that the reference signal by definition is selected because it matches the one or more sensed evoked resonant neural activity signals. It is unclear how to reconcile how the one or more sensed evoked resonant neural activity signals can conditionally match a selected reference signal when the selected reference signal is defined by matching the one or more sensed evoked resonant neural activity signals. This ambiguity renders claim 18 indefinite.
Claims 19 is rejected by virtue of their dependence from claim 18.
Claim 19 recites “a target anatomical location” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a target anatomical location” of claim 18, line 27. If they are the same, “a target anatomical location” in claim 19 should be “the target anatomical location”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 19 recites “a stored reference signal” in line 4, but it is not clear if this recitation is the same as, related to, or different from “a selected reference signal” of claim 18, line 27. Both recitations appears to be alluding to the same thing, but their different phraseology suggests that they are different. Clarification between the two recitations is required. Relatedly, it is not clear if “determine a stored reference signal of the multiple reference signals for the target anatomical location” of lines 4-5 is the same as, related to, or different from “match the one or more sensed evoked resonant neural activity signals to a selected reference signal of the multiple reference signals” of claim 18, lines 21-22. Both recitations appear to be alluding to the same thing, but their different phraseology suggests that they are different. Clarification between the two recitations is required.
Claim 19 recites “an indication” in line 6, but it is not clear if this recitation is the same as, related to, or different from “an indication” of claim 18, line 26. Both recitations appear to be alluding to the same thing, but their different phraseology suggests that they are different. Clarification between the two recitations is required. Relatedly, it is not clear if “generate an indication via the user interface that the implantable electrode is positioned at the target anatomical location” in lines 6-7 is the same as, related to, or different from “generate an indication that the implantable electrode is positioned at a target anatomical location corresponding to the selected reference signal when the determined depth of anesthesia corresponds to the received anesthesia state information and the one or more sensed evoked resonant neural activity signals match the selected reference signal” of claim 18, lines 26-30. Both recitations appear to be alluding to the same thing, but their different phraseology suggests that they are different. Clarification between the two recitations is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 5-6, 9, and 11 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1, 5-6, 9, and 11 are directed to a method of processing neural signals using a computational algorithm, which is an abstract idea. Claims 1, 5-6, 9, and 11 do not include additional elements that integrate the exception into a practical application or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), and the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, page 50, January 7, 2019).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is drawn to a machine.
Step 2A – Prong One: Claim 1 recites an abstract idea. In particular, claim 1 recites the following limitations:
[A1] an anesthesia response map that includes reference signals stored in association with anatomical locations and with one or more of a type of general anesthetic drug and a dose of the general anesthetic drug, wherein the reference signals are representative of local or network neural activity signal associated with a state of arousal at or near the anatomical locations;
[B1] receive anesthesia state information for the subject including an indication of the one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug;
[C1] compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion;
[D1] determine a depth of anesthesia of the subject according to the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal.
These elements [A1]-[D1] of claim 1 are drawn to an abstract idea since they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Step 2A – Prong Two: Claim 1 recites the following limitations that are beyond the judicial exception:
[A2] a sensing circuit configured to sense one or more evoked resonant neural activity signals representative of neural activity of a subject when connected to an implantable electrode of the one or more implantable electrodes;
[B2] a memory to store …;
[C2] processing circuitry in communication with the sensing circuit and the memory;
[D2] generate an indication that the implantable electrode is positioned at a target anatomical location corresponding to the selected reference signal when the determined depth of anesthesia corresponds to the received anesthesia state information and the one or more sensed evoked resonant neural activity signals match the selected reference signal.
These elements [A2]-[D2] of claim 1 do not integrate the exception into a practical application of the exception. In particular, the element [A2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Furthermore, the elements [B2] and [C2] are merely instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). The element [D2] is merely adding insignificant extra-solution activity to the judicial exception, i.e., merely displaying the results of the algorithm that uses conventional, routine, and well known elements.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. In particular, the element [A2] is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements. In particular, the sensing circuit is nothing more than one or more sense amplifiers that sense neural signals. Such sense amplifiers are conventional as evidenced by paragraph 0007 of U.S. Patent Application Publication No. 2007/0173732 (Causevic)(previously cited), which discloses that implanted electrodes and amplification circuits are typical.
Further, the elements [B2] and [C2] do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The element [D2] is merely insignificant extrasolution activity to the judicial exception, e.g., merely outputting the results of an algorithm in conjunction with the abstract idea that uses conventional, routine, and well known elements. That is, the display of the output is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Claims 5-6, 9, and 11 depend from claim 1, and recite the same abstract idea as claim 1. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the algorithm), with the following exceptions:
Claim 5: “the implantable electrode, and the implantable electrode is configured for placement at or near a basal ganglia structure of the subject”;
Claim 6: the sensing circuit and the processing circuitry;
Claim 9: the processing circuitry and the generation of an indication of the depth of anesthesia of the subject according to the determined measure of association; and
Claim 11: the processing circuitry.
Each of these claims limitations does not integrate the exception into a practical application. In particular, the implantable electrodes of claim 5 and the sensing circuit of claim 6 are merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). The processing circuitry of claims 6, 9 and 11 are merely instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). The generation of the indication of claim is merely adding insignificant extra-solution activity to the judicial exception, i.e., merely displaying the results of the algorithm that uses conventional, routine, and well known elements.
Also, each of these limitations does not recite additional elements that amount to significantly more than the judicial exception itself because they are merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements. In particular, the element of claim 5 is nothing more than an implantable DBS electrode. Such electrodes are conventional as evidenced by:
paragraph 0007 Causevic, which discloses that implanted electrodes and amplification circuits are typical; and
paragraph 0490 of U.S. Patent Application Publication No. 2019/0321106 (Bergman)(previously cited) which discloses that DBS electrodes are commonly used.
The element of claim 6 is nothing more than one or more sense amplifiers that sense neural signals. Such sense amplifiers are conventional as evidenced by paragraph 0007 Causevic, which discloses that implanted electrodes and amplification circuits are typical (see the above rejection of claim 1).
Also, the processing circuitry of claims 6, 9, and 11 are simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The generation of the indication of claim 9 is merely insignificant extrasolution activity to the judicial exception, e.g., merely outputting the results of an algorithm in conjunction with the abstract idea that uses conventional, routine, and well known elements. That is, the display of the output is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions (that is, one of display) that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations of each claim as an ordered combination in conjunction with the claims from which they depend (that is, as a whole) adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Allowable Subject Matter
Claims 1, 5-6, 9, and 11 would be allowable if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and under 35 U.S.C. 101 set forth in this Office action.
Claims 2 and 7 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 13-15 and 17-19 would be if rewritten to overcome the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph set forth in this Office action.
The following is an examiner’s statement of reasons for allowance.
U.S. Patent Application Publication No. 2019/0143120 (Sinclair 120)(previously cited) teaches a medical system for coupling to one or more implantable electrodes (the implanted electrodes of Sinclair 120; abstract, paragraphs 0004, 0016, 0033, 0056, 0071, 0140-0142, 0153, 0156, 0163-0168, and 0208-0211 of Sinclair 120; FIGS. 8-9 and 13-14 of Sinclair 120), the system comprising: a sensing circuit configured to sense one or more neural activity signals representative of neural activity of a subject when connected to an implantable electrode of the one or more implantable electrodes (the measurement circuit 96 of Sinclair 120); a memory (the memory 102 of Sinclair 120; paragraphs 0157, 0169, 0182 of Sinclair 120) to store a reference signal (paragraphs 0165-0166 and 0170 of Sinclair 120); and processing circuitry (the processing unit 92 of Sinclair 120) in communication with the sensing circuit and the memory, the processing circuitry configured to: compare the one or more sensed evoked resonant neural activity signals to the reference signal (the comparison of Sinclair 120; paragraphs 0165-0166 and 0170 of Sinclair 120) and generate an indication of the anatomical location corresponding to the reference signal as the location of the implantable electrode (paragraphs 0161, 0165-0166 and 0170-171 of Sinclair 120).
Sinclair 120 teaches that the method and system can be used when a patient is under sedation or general anesthetic during surgery (paragraph 0156 of Sinclair 120). Further, Sinclair 120 teaches that a map of evoked response at different locations may be generated (paragraph 0165 of Sinclair 120). U.S. Patent Application Publication No. 2019/0321106 (Bergman)(previously cited) teaches that tissue maps may include signals associated with anatomical regions and different physiological states, such as sleeping/awareness, which is beneficial to know during surgery (paragraph 0569 and 0572-0575 of Bergman). U.S. Patent Application Publication No. 2021/0236821 (Sinclair 821)(previously cited) teaches that comparing ERNA to references provides a supportive indication of a patient’s consciousness that is beneficial during general anesthesia generally (paragraph 0246 of Sinclair 821). Thus, ERNA are also the type of signals associated with different physiological states. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have each reference signal associated with a specific anatomical location and representative of the depth of sleep and/or awareness of the patient since (1) it provides more accurate results when determining location and (2) it provides a level of awareness of the patient during surgery. Thus, the combination teaches or suggest that the reference signal is representative of a local or network neural activity signal associated with a state of arousal at or near an anatomical location of the subject and the step of determine a depth of anesthesia of the subject according to the comparison of the one or more sensed neural activity signals and the reference signal.
U.S. Patent Application Publication No. 2020/0327995 (Ye)(previously cited) discloses a method including the steps of acquiring an electroencephalogram signal by means of an electroencephalogram sensor; selecting a target anesthesia depth model from an anesthesia depth model database according to the type of a drug for anesthesia, each anesthesia depth model of the anesthesia depth model database being trained according to a specific drug type, a corresponding electroencephalogram signal, and a marked anesthesia depth; and obtaining an anesthesia depth value on the basis of the target anesthesia depth model and the electroencephalogram signal (Abstract of Ye). However, Ye does not teach or suggest that such a regime is applicable to the neural activity signals, such as the signals of Sinclair 120.
With respect to claim 1, the prior art (including Ye) does not teach or suggest “a memory to store an anesthesia response map that includes reference signals stored in association with anatomical locations and with one or more of a type of general anesthetic drug and a dose of the general anesthetic drug… the processing circuitry configured to…compare the one or more sensed evoked resonant neural activity signals to the reference signals and select a reference signal using a matching criterion; determine a depth of anesthesia of the subject according to the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal” along with the other features of claim 1.
Claims 2, 5-7, 9, and 11 are allowable by virtue of their dependence from claim 1.
With respect to claim 13, the prior art (including Ye) does not teach or suggest “receiving anesthesia state information for the subject including an indication of the one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug; matching the one or more sensed neural activity signals to select a reference signal of the multiple stored reference signals, wherein the one or more sensed neural activity signals are only compared to those reference signals of the multiple stored reference signals corresponding to the indication of the one or both of the received type of anesthesia drug and dose of the anesthesia drug; determining a depth of anesthesia of the subject according to the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal” along with the other features of claim 13.
Claims 14-15 and 17 are allowable by virtue of their dependence from claim 13.
With respect to claim 18, the prior art (including Ye) does not teach or suggest “a memory to store multiple reference signals in an anesthesia response map in association with respective anatomical locations and with one or more of a type of general anesthetic drug and a dose of the general anesthetic drug…the processing circuitry configured to: receive anesthesia state information for the subject including an indication of one or more of the type of the general anesthetic drug and the dose of the general anesthetic drug…compare the one or more sensed evoked resonant neural activity signals to those reference signals of the multiple reference signals corresponding to the indication of the one or both of the type of anesthesia drug and the dose of the selected anesthesia drug; match the one or more sensed evoked resonant neural activity signals to a selected reference signal of the multiple reference signals; determine a depth of anesthesia of the subject according to the comparison of the one or more sensed evoked resonant neural activity signals and the selected reference signal” along with the other features of claim 18.
Claim 19 is allowable by virtue of their dependence from claim 18.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
The Applicant’s arguments filed 11/11/2025 have been fully considered.
Claim objections
There are new grounds of claim objections that were necessitated by the claim amendments filed on 11/11/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 11/11/2025.
35 U.S.C. 101
In view of the claim amendments filed on 11/11/2025, the rejections of claims 13-16 are withdrawn.
There are new grounds of claim rejections under 35 U.S.C. 101 that were necessitated by the claim amendments filed on 11/11/2025.
The Applicant asserts:
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This argument is not persuasive since the use of the memory for storage does not integrate the exception into a practical application of the exception. It is merely an instruction to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f). Also, the use of the memory for storage does not amount to significantly more than the judicial exception itself. It is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
The use of the sensing circuit does not integrate the exception into a practical application of the exception. It is merely adding insignificant extra-solution activity to the judicial exception, i.e., mere data gathering at a higher level of generality - see MPEP 2106.04(d) and MPEP 2106.05(g). Also, the use of the sensing circuit does not amount to significantly more than the judicial exception itself. It is merely insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with the abstract idea that uses conventional, routine, and well known elements. In particular, the sensing circuit is nothing more than one or more sense amplifiers that sense neural signals. Such sense amplifiers are conventional as evidenced by paragraph 0007 of U.S. Patent Application Publication No. 2007/0173732 (Causevic)(previously cited), which discloses that implanted electrodes and amplification circuits are typical.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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